BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1324854 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-02581
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    May 16, 2007
    Report Date
    May 16, 2007
    Manufacturer
    NORTH AMERICAN STERILIZATION AND PACKAGING CO.
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS REPORTED FOR THE PATIENT HAVING DIFFICULTY BREATHING DURING THE PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE PERTINENT LOT BY THE MANUFACTURER NASP. THE REVIEW SHOWED THAT ALL IN PROCESS AND FINAL RELEASE TESTING WAS PERFORMED IN ACCORDANCE WITH THE APPROPRIATE PROCEDURES. NO EVIDENCE OF A MANUFACTURING RELATED, POTENTIAL CAUSE FOR THIS TYPE OF EVENT WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDROTHERMABLATOR PROCEDURE SET WAS USED DURING A ENDOMETRIAL ABLATION PROCEDURE PERFORMED IN 2007 (FEMALE PATIENT; AGE AND WEIGHT ARE UNKNOWN). DURING THE HEAT UP STAGE OF THE PROCEDURE, THE PATIENT FELT LIKE SHE COULD NOT BREATHE AND AT THAT TIME THE PHYSICIAN ABORTED THE PROCEDURE AND CALLED THE PAREMEDICS TO COME AND TAKE THE PATIENT TO THE EMERGENCY ROOM. THE PHYSICIAN INDICATED THAT SHE FELT IT WAS RELATED TO THE PATIENT NOT RESPONDING TO THE MEDICATION THAT SHE WAS PRESCRIBED PRIOR TO THE PROCEDURE. THE REP CALLED TO MENTIONED THAT THE PATIENT WAS GIVEN THE NORMAL DOSAGE RECOMMENDED PER TREATMENT NOTHING OUT OF THE ORDINARY TO EXPLAIN THE EVENT. HE STATED THAT THE PATIENT MAY HAVE A LOW TOLERANCE TO PAIN. THE PATIENT WAS KEPT IN THE ER FOR OBSERVATION FOR ABOUT FIVE HOURS THEN RELEASED. THE DOCTOR SAW THE PATIENT THE NEXT DAY AND SHE APPEARED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB MNB NORTH AMERICAN STERILIZATION AND PACKAGING CO. M006560201 0000031982

    Patients

    Seq Age Sex Outcome Treatment
    1 Other